GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

November 3, 2008 updated by: Cell Genesys

A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

626

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, B-2020
        • ZNA Middelheim
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Edegem, Belgium, 2650
        • University Hospital Antwerp (UZA)
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, B-9000
        • Unversity Hospial Gent
      • Hasselt, Belgium, B-3500
        • Virga Jesse Ziekenhuis
      • Kortrijk, Belgium, B-8500
        • AZ Groeninge
      • Roeselare, Belgium, B-8800
        • Heilig Hartziekenhuis Roeselare Men
      • Sint-Truiden, Belgium, B-3800
        • Regionaal Ziekenhuis Sint Trudo
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM Notre-Dam
      • Montreal, Quebec, Canada, H2W1S6
        • McGIll University
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Ultra Med Inc.
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hopitalier Universitaire de Sherbrooke
  • France
      • Angers Cedex, France, 49033
        • Centre Paul Papin
      • Caen Cedex 5, France, 14076
        • Centre Francois Baclesse
      • Dijon Cedex, France, 77980
        • Centre Georges François Leclerc
      • Lyon Cedex, France, 08
        • Centre Leon Berard Service de Cancerologie Medicale
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Nantes-Saint Herblain, France, 44805
        • Centre René Gauducheau
      • Reims Cedex, France, 51056
        • Institut Jean Godinot
      • Vandoeuvre les Nancy Cedex, France, 54511
        • Centre Alexis Vautrin
  • Germany
      • Aachen, Germany, 52074
        • Universitatsklinikum Aachen Urologie
      • Dresden, Germany, 1307
        • der Technischen Universitat Dresden
      • Essen, Germany, 45122
        • Universitatsklinik um Essen
      • Homburg/Saar, Germany, 66421
        • Universitatsklinik um des Saarlande
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum
      • Groningen, Netherlands
        • University Medical Centre Groningen
  • Sweden
      • Linkoping, Sweden
        • University Hospital, Linköping
      • Lund, Sweden
        • University Hospital Lund
      • Uppsala, Sweden, 85
        • Akademiska University hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology Centre
      • Leeds, United Kingdom, LS97TF
        • St. James's University Hospital
      • London, United Kingdom, W12 0NN
        • Hammersmith Hospital
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hosptial
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Oxford, United Kingdom, OX3 7LT
        • Oxford Cancer Centre, Churchill Hospital
      • Scunthorpe, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • Wales, United Kingdom, LL18 5UJ
        • Glan Clwyd Hospital
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Central Alabama Oncology, LLC
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology/Oncology
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
      • Tuscon, Arizona, United States, 85715
        • ACRC/Arizona Clinical Res. Ctr. Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center
    • California
      • Corona, California, United States, 92882
        • Compassionate Cancer Care Medical Group, Inc.
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hem Onc. Medical Group
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • La Mesa, California, United States, 91942
        • Center for Urological Research
      • Montebello, California, United States, 90640
        • Oncology Care Medical Associates
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • San Bernardino, California, United States, 92404
        • San Bernardino Urological Associates
      • San Diego, California, United States, 92123
        • Sharp HealthCare
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • Soquel, California, United States, 95073
        • Cancer Research & Prevention Center
      • Vista, California, United States, 92081
        • San Diego Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univ. of Colorado Health Science Center
      • Colorado Springs, Colorado, United States, 80907
        • Cancer Center of Colorado Springs
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • The Hope Clinic
      • New Britain, Connecticut, United States, 06052-1395
        • Urology Center of Grove Hill
      • Stamford, Connecticut, United States, 06902
        • Carl & Dorothy Bennett Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Community Hospital, Inc.
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida/Advanced Medical Specialists
      • Ocoee, Florida, United States, 34761
        • Cancer Centers of Florida
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
      • Safety Harbor, Florida, United States, 34695
        • Urology Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
      • Atlanta, Georgia, United States, 30033
        • Atlanta VAMC
      • Atlanta, Georgia, United States, 30084
        • Georgia Cancer Specialists
      • Atlanta, Georgia, United States, 30309
        • Peachtree Hematology Oncology Consultants, PC
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care, P.C.
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic & Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic Research Center
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Medical Oncology/Hematology Inc.
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Louisiana Oncology Associates
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital Regional Cancer Therapy Center
    • Michigan
      • Free Soil, Michigan, United States, 49411
        • West Michigan Regional Cancer and Blood Center
      • Royal Oak, Michigan, United States, 48073-6706
        • William Beaumont Hospital, Cancer Clinical Trials Office
      • Southfield, Michigan, United States, 48075
        • Newland Medical Associates, P.C.
    • Missouri
      • St. Louis, Missouri, United States, 63136
        • Hematology Oncology Consultants, Inc.
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic
      • Billings, Montana, United States, 59101
        • Hematology/Oncology Centers of the Northern Rockies, P.C.
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Omaha VA Medical Center
      • Omaha, Nebraska, United States, 68198-7680
        • Omaha VA Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer & Hematologic Disease
      • Morristown, New Jersey, United States, 07962
        • Hematology-Oncology Associates of Northern New Jersey
      • Summit, New Jersey, United States, 07901
        • Summit Medical Group/Overlook Oncology Center
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital/ Center for Cancer Research
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina Hematology Oncology, PA
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Cancer Care / Odyssey Research
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation, Taussig Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Urologic Surgery PC
      • Kingston, Pennsylvania, United States, 18704
        • Medical Oncology Associates
      • Lancaster, Pennsylvania, United States, 17604
        • Urological Associates of Lancaster
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster Cancer Center, Ltd
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Health Care System
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Texas
      • Amarillo, Texas, United States, 79106
        • The Don and Sybil Harrington Cancer Center
      • Dallas, Texas, United States, 75201
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment PA
      • Dallas, Texas, United States, 75231
        • Urology Specialists and Associates, P.A.
      • Houston, Texas, United States, 77024
        • Mobley Research Center
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Oncology Research Department
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • Any Gleason score
  • ECOG performance status 0-2

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 2
Standard of care - chemotherapy
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
EXPERIMENTAL: 1
Immunotherapy
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Bone pain and bone related events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Genesys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

August 16, 2004

First Submitted That Met QC Criteria

August 17, 2004

First Posted (ESTIMATE)

August 18, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2008

Last Update Submitted That Met QC Criteria

November 3, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-0029
  • (VITAL-1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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